Mitral Paravalvular Leaks (PVL)NCT03003481
Follow-up Registry to Monitor the Efficacy and Safety of the Occlutech PLD Device
An observational study of Mitral Paravalvular Leaks (PVL) and Aortic Paravalvular Leaks (PVL), run by Occlutech International AB at 1 site in Italy.
Trial summary
Collect patient data and to monitor the clinical use (safety and efficacy) of the device Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Paravalvular Leaks (PVL), Aortic Paravalvular Leaks (PVL)
- How many people
- 144 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2016to May 2021
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with aortic or mitral PVL
Who may be able to join
- Patients with PVL associated hemolysis, recurrent blood transfusions, or hemodynamically significant heart failure
Who cannot join
- The device is contraindicated for patients known to have any of the following:
- Known coagulation dysfunction
- Leak reversal with separate or significant residual or recurrent leak
- Acute infection
- Known intra-cardiac thrombi
- Recent pelvic venous thrombosis
Show all 9Show fewer
- Recent myocardial infarction or a surgical bypass operation in the last 30 days
- If adequate oral anticoagulation therapy / antiplatelet aggregation inhibition is not possible post-procedurally
- Intolerance of contrast agent
Trial locations and contacts
1 site in 1 country.
About this study
Collect patient data and to monitor the clinical use (safety and efficacy) of the device
What is being measured
The primary outcome is the main question the study is designed to answer.
Proper closure of the PVL (defined as Reduction in paravalvular regurgitation of ≥ one grade as assessed by echocardiography pre vs post implantation) and/or reduction in the number of hemolysis related transfusions.
Measured: 6 month following implantation
Absence of device -and/or procedure-related Serious Adverse Events (SAEs) including deaths, stroke (ischemic stroke that occurs within 24 hours following implantation), systemic embolism or device embolizations.
Measured: 6 month following implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study startOct 2016
- Primary completionMay 2021
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Paravalvular Leaks (PVL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Occlutech International AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003481
- Sponsor's protocol ID
- Occ2016_01
- Status last verified
- Apr 2022
- First submitted
- 24 Oct 2016
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Registry to Monitor the Efficacy and Safety of the Occlutech PLD Device
- ClinicalTrials.gov ID
- NCT03003481
- Acronym / sponsor ID
- Occ2016_01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Occlutech International ABIndustry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- May 2021 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 28 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Collect patient data and to monitor the clinical use (safety and efficacy) of the device
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 4 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with aortic or mitral PVL
Key inclusion criteria (1 listed)
- Patients with PVL associated hemolysis, recurrent blood transfusions, or hemodynamically significant heart failure
Key exclusion criteria (9 listed)
- Known coagulation dysfunction
- Leak reversal with separate or significant residual or recurrent leak
- Acute infection
- Known intra-cardiac thrombi
- Recent pelvic venous thrombosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proper closure of the PVL (defined as Reduction in paravalvular regurgitation of ≥ one grade as assessed by echocardiography pre vs post implantation) and/or reduction in the number of hemolysis related transfusions.
Time frame: 6 month following implantation
Absence of device -and/or procedure-related Serious Adverse Events (SAEs) including deaths, stroke (ischemic stroke that occurs within 24 hours following implantation), systemic embolism or device embolizations.
Time frame: 6 month following implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
Related trials for Mitral Paravalvular Leaks (PVL)
Enrolling by invitationObservational study
A Multicenter, International, Prospective and Retrospective, Follow-up Registry to Monitor the Efficacy and Safety of the Occlutech Paravalvular Leak Device (PLD) in Patients With Mitral or Aortic Paravalvular Leaks
Paravalvular Leak
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Paravalvular Leaks (PVL) and Aortic Paravalvular Leaks (PVL), run by Occlutech International AB at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proper closure of the PVL (defined as Reduction in paravalvular regurgitation of ≥ one grade as assessed by echocardiography pre vs post implantation) and/or reduction in the number of hemolysis related transfusions. (time frame: 6 month following implantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.